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Digital Guide and Supporter, AI and Software in Healthcare,
Regulatory, Quality, Compliance and Policy.
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Join date: Oct 3, 2024
Posts (5)
Aug 31, 2025 ∙ 15 min
Analysis of Software as a Medical Device (SaMD) Compliance in App Store Applications: A Critical Review of Regulatory Oversight and App Store Accountability
This report presents a comprehensive analysis of Software as a Medical Device (SaMD) compliance within applications available on the Google Play Store. We analyzed Google Play listings (noting parallel availability on Apple’s App Store where visible) listings observed between 1 April –2 April 2025 (time zone: Europe/Berlin) in the USA and Germany store configuration. Results reflect what was publicly displayed during that time. Our review focused on applications making clinical claims, categoriz
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Mar 5, 2025 ∙ 3 min
Why RFK jr. reshaping US FDA into an information only authority is not bad although it is.
DALL-E generated Robert F. Kennedy Jr.'s proposed reorganization of the Food and Drug Administration (FDA) envisions a groundbreaking...
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Feb 2, 2025 ∙ 5 min
EU AI Act (2024/1689) and EU MDR (2017/745): Breaking the Expensive Myth: Why AI-Powered Medical Devices Under EU MDR Don’t Need EU AI Act Certification – A Detailed Analysis of Regulatory Requirement
DOI: 10.70317/2025.02rw02 1. Introduction: A Looming Compliance Nightmare or a Simple Fix? With Artificial Intelligence (AI) reshaping...
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Rudolf Wagner
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Thought Leader, Speaker and Digital Enthusiast
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